IPKN MOIST AND FIRM BEAUTY BALM LIGHT MEDIUM- titanium dioxide cream

IPKN Moist and Firm Beauty Balm Light Medium by

Drug Labeling and Warnings

IPKN Moist and Firm Beauty Balm Light Medium by is a Otc medication manufactured, distributed, or labeled by Inel Cosmetics Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 6.51%

PURPOSE

Sunscreen

INDICATIONS & USAGE

 Helps prevent sunburn
 If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin aging caused by the sun

DOSAGE & ADMINISTRATION

For sunscreen use:
 Apply liberally 15 minutes before sun exposure
 Reapply at least every two hours
 Use a water-resistant sunscreen if swimming or sweating
 Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
 Ask a doctor to use for children under 6 months

WARNINGS

 For external use only
 Do not use on damaged or broken skin
 Stop using and ask a doctor if rash occurs
 When using this product, keep out of eyes. Rinse with water to remove
 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

INACTIVE INGREDIENT

Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Glycerin, Iron Oxides (CI 77492), PEG-10 Dimethicone, Phenyl Trimethicone, Triethylhexanoin, Isododecane, Octyldodecanol, Cetyl Ethylhexanoate, Dipropylene Glycol, Hexyl Laurate, Isoeicosane, Niacinamide, Pentylene Glycol, Mica (CI 77019), Butylene Glycol Dicaprylate/Dicaprate, Disteardimonium Hectorite, Panthenol, Talc, Magnesium Sulfate, Iron Oxides (CI 77491), Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Iron Oxides (CI 77499), Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Triethoxycaprylylsilane, Stearic Acid, Alumina, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Isopropyl Titanium Triisostearate, Hydrolyzed Hyaluronic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Adenosine, Trisodium Ethylenediamine Disuccinate, Moringa Oleifera Seed Oil, Ceramide NP, Phytosphingosine, Hydrogenated Lecithin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

IPKN MOIST AND FIRM BEAUTY BALM LIGHT MEDIUM 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43526-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (CI 77891 - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	65.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOEICOSANE (UNII: AR294KAG3T)
NIACINAMIDE (UNII: 25X51I8RD4)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
MICA (UNII: V8A1AW0880)
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
PANTHENOL (UNII: WV9CM0O67Z)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
GLYCERYL BEHENATE/EICOSADIOATE (UNII: 73CJJ317SR)
GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)
HYALURONIC ACID (UNII: S270N0TRQY)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
ADENOSINE (UNII: K72T3FS567)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
CERAMIDE NP (UNII: 4370DF050B)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERIN (UNII: PDC6A3C0OX)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
PEG-10 DIMETHICONE (200 CST) (UNII: 287GF3Y3WC)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISODODECANE (UNII: A8289P68Y2)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL ETHYLHEXANOATE (UNII: 134647WMX4)
DIPROPYLENE GLYCOL (UNII: E107L85C40)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43526-129-02	1 in 1 CARTON	10/25/2024
1	NDC: 43526-129-01	40 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/25/2024

Labeler - Inel Cosmetics Co., Ltd. (688038939)

Registrant - Inel Cosmetics Co., Ltd. (688038939)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(43526-129)